Technical Update TAA.TU rev. 1

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1 Technical Update TAA.TU rev. 1 Effective: 2011 Sep 30 CO# Product: Subject: From: PrismaFlex 5.10 Software Release Technical Preview for Service Personnel Colin Campbell, Dave Dotson Revision 5.10 Upgrade - Hardware and Software for the US market In this update Gambro announces the release of 5.10 software for the USA market. It includes hardware and software enhancements to the Prismaflex as well as new features. Gambro is actively planning the logistics and schedule to upgrade all Prismaflex systems in the USA as quickly as possible over the next year. Gambro will perform the 5.10 upgrades at all customer sites at no cost to the customer. Additional optional services may be purchased by the customer and also completed during the upgrade. In summary, the 5.10 upgrade includes new features and improvements to both the existing hardware and software. The TPE therapy has been added; improvements have been made to the syringe pump assembly and the main control computer in the system; software enhancements include an improved graphical user interface and improved alarm handling. There is also enhanced documentation for both operator and service personnel, as well as, enhanced service features, and more. This document describes the changes for the benefit of those who service the systems. New Features Added: TPE Treatment and Filter Set New functionality is available with TPE as a treatment option. This option will be unlocked with a machine specific code, upon request, by the Gambro Field Service Representative during the installation of the 5.10 upgrade. It will use the TPE 2000 filter set. TPE is a therapy that has been used on the Gambro Prisma worldwide, as well as, on Prismaflex systems in other countries. TPE is used to remove large plasma proteins including immune complex, antibodies, poisons, and inflammatory mediators. Replacement fluid is used to replace the plasma that was removed. Albumin is frequently used to enhance the oncotic pressure and replace volume in the vascular space. FFP is used to replace anticoagulation factors and other plasma constituents. Crystalloids such as NS or LR are used to replace volume. Detection of a Faulty Scale In some cases excessive side forces affecting the scales can cause the overload protection to come in contact with the base of the scale creating nuisance alarms or mis-calibration. The 5.10 software will detect this failure mode and generate an alarm during the treatment indicating a Page 1 of 6

2 scale may be out of calibration. When this occurs it is crucial that a complete calibration and verification be performed, and any faulty scale should be replaced. Barcode for Identification of Hardware Status In the service mode, and on one of the service screens, there will be a two-dimensional barcode displayed that describes the hardware configuration and status of the machine. When requested, a photo of this screen can be taken and ed to Gambro to aid in troubleshooting. Battery Back-Up (optional) This feature includes a new version of the Power Supply and a new 24 volt (2x12) battery. It allows the machine to remain fully functional for as long as the charge of the battery set may last. The battery charge level is checked automatically during the Self-Test ensuring a continuous daily update of the battery condition and status. Should it fail the test an alarm will be given. Note: The new power supply and batteries are not part of the standard 5.10 upgrade and must be ordered separately, if this feature is to be implemented on existing systems. New machines include the battery backup feature and will automatically come with everything pre-installed. The batteries and power supply will also be available as spare parts. General Improvements: The upgrade includes many improvements which increase the user friendliness of the system: I/O Reminder Beep The I/O reminder function from the Prisma system is now also present in Prismaflex. Self-Test Audible Alarm Mute With the 5.10 software it will be possible to mute the self-test alarm via settings in custom mode. Flow Rate Parameters & Recirculation Flow rate parameters will be saved, allowing you to continue the treatment after recirculation. Change in Bag Volume Increments It will now be possible to set the bag volume in steps of 100 ml s instead of the 250 ml increment used in previous software versions. Cancellation of Bag Volume Advisory The 5 liter limit advisory alarm for the 9 liter effluent bag has been removed. Load and Bar Code Check During loading two conditions could trigger the "Warning: Wrong Set Loaded" alarm, an incompatibility between the Therapy chosen and the Set used, and a failure of the recognition test. In the 5.10 software this is now be divided into two different alarms, "Warning: Wrong Set Loaded" for the incompatibility and "Warning: Set-up error" for failure of the recognition test. Page 2 of 6

3 PM Changes The PM timer will now be able to be set based on the date and operating hours. The full PM is still recommended for every 12 months; changing of the sealing cones every 6 months as a separate procedure is no longer necessary. Access Pressure Range The auto detection of the access pressure range has been removed. Instead, the user will be able to choose which range to use (positive or negative) before the treatment starts. Same patient options When choosing same patient the flow rates will be saved. It will also be possible to select a different treatment therapy. Removed the No flow in blood path alarm This alarm would occur if the delta pressure between the Filter transducer and the Return transducer was too close to 0 mmhg. It is no longer present in the 5.10 software version. Handling of too low return pressure There is a warning "Return Disconnected". It can be deactivated by pressing Continue. The new working range will then be less than 10 mmhg. The warning will not appear again after taking this action. However, an advisory alarm "Cannot detect return" will be issued if the pressure remains near 0 mmhg. It can be overridden. If overridden, no further alarm/advisory will be issued. Improvements in PCMCIA data The PCMCIA data will be automatically downloaded at the end of a treatment. It will also track more events such as change bags, automatic syringe boluses, unknown set and system tools (e.g. adjust the Deaeration chamber level, BLD normalization). Frozen screen All known cases of the frozen screen (display lock-up) are now captured, managed, and solved. Split of Blood detected in set alarm screens Changes have been made to separate indications of the Blood detected in set alarm between when in recirculation and when after or prior to being in treatment. User Improvements: Several human factor studies and key user tests have lead to a substantial update of the user interface and user friendliness of the Prismaflex. Following are the main changes to Prismaflex: Updated drawings in the GUI (Graphical User Interface) relating to changes in managing frangible pins; designed specifically for non-pvc Gambro bags. Page 3 of 6

4 More causes for the various caution: XXX weight scale weight alarms are displayed to improve troubleshooting. Color coding of the scales and tubing in scale-related alarm screens. The Adjust Chamber Softkey that appears after Release Clamp (from an Air in Blood alarm) has been removed, as it has no function in this context. Identification of which bag is clamped when the Clamped Bag alarm occurs. The excess fluid gain/loss is now displayed in the history screen and available to the user. The Scale component missing alarm has been inactivated during set-up of the machine. Stop key will now work after reaching the 780 liters blood processed limit. Improved the stop of treatment sequence after an Excess Fluid Loss or Gain alarm. Increased blood flow rate during the blood return process is now possible. Improved the ability to detect leaks or partially clamped bags. Improved fluid balance handling with a UF rate focus. Communication Improvements: Internal Communication Many improvements regarding the internal communications of the Prismaflex have been implemented in the 5.10 software. All known causes of unjustified General System Failure and Memory Error 6 alarms have been managed and resolved. External Communication Some cases of data disruption were seen in the external data connection for RS232, after patient disconnect. This has been now been corrected. The machine ID for therapy and set enabling codes will be present in the PCMCIA data. The external communication protocol has been updated. The Communication Programmers Guide has been updated according to the changes in the communication protocol. Syringe Improvements: Automatic loading/testing The loading of the syringe will be automatic in 5.10 software, as will the test during setup. Volume added in history The syringe pump volume delivered is now displayed in the history screen. In other countries the syringe pump may now also be used to deliver calcium compensation (i.e., for citrate solutions). Page 4 of 6

5 Other improvements of the syringe pump The following have been included in the 5.10 software to reduce nuisance alarms: Unjustified syringe pump malfunction alarms have been managed and resolved. Improvements in the calibration sequence and the calibration values stored. An updated test for the Syringe Pump; to improve stability and reliability. To make it easier to remove the Syringe, the Syringe Control Panel is now functional in the Remove Set screen. Changes in the GUI To align itself with the new loading sequence, the GUI has also been updated. Supported syringe brands and sizes are updated: 10 ml 20 ml 30 ml 50 ml BD Plastipak 10 BD Plastipak 20 BD Plastipak 30 BD Plastipak 50 Terumo 10 Terumo 20 Terumo 30 Terumo 50 Braun (Omnifix) 10 Braun (Omnifix) 20 ICO Gamma Plus 30 Codan Luer Lock 50 Kendall Monoject 20 PIC 30 LL Fresenius Injectomat 50 Braun (Omnifix) 30 Ecoject 50 Kendall Monoject 50 Braun (Omnifix) 50 Documentation Improvements: There are substantial updates to all documentation. New information is included. For example, use of acidic priming solution is now well known in Chronic Hemodialysis as a factor of Patient Reaction. This issue is less visible in CRRT and less known to non-nephrologists. To assure safe usage we have strengthened the labeling and reference information in our manuals and brochures. Paper Version Operator s Manual English US Operator's Manuals CRRT+TPE - Only for US G CD-ROM Version Operator s Manual Operator s Manual on CD US - Only for US G Paper Version Service Manual Service Manual US CRRT+TPE, English - Only for US G CD-ROM Version Service Manual Service Manual CD, CRRT+TPE US - Only for US G Communication Programmer s Guide Communication Programmer s Guide English G Page 5 of 6

6 Spare Parts Update PC Upgrade Kit G New PC104 board including adapters for the old Display and Bar Code Reader Compact Flash for Revision 4.00 and above G was not implemented in the US. However, the Flash may be used with a 5.10 SW upgrade. Software CD Revision 5.10 G Bootable software CD with Revision 5.10 software. Scale tube clips G Includes the improved upper scale tube clips. Syringe Pump G New syringe pump allowing for the use of calcium compensation. Battery Backup (optional) G V battery backup to run the machine with full functionality for the life of the battery s charge. Note: Everything needed to install the spare part is included in the respective spare part kit. All new 5.10 components and spare parts are not backward compatible with 3.20 software machines. Page 6 of 6

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